Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-T
FDA device recall Z-0300-2021 · posted 2020-10-27 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- The Streamline Navigation System taps have experienced binding with other devices.
- Action taken
- On September 24, 2020, the firm distributed the Urgent Medical Devices Recall letter to customers. Customers were instructed to remove affected product from all user sites and inventory locations. These instrument systems are to be returned to RTI Surgical along with a completed copy of the response form. Accounts who have further distributed the affected products are also asked to immediately notify their customers by providing them a copy of the recall letter and the response form for completion when returning the affected devices to RTI Surgical.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 420
- Distribution
- US Nationwide distribution including in the state of Michigan.
- Date initiated
- 2020-09-24
- Date posted
- 2020-10-27
- Date terminated
- 2024-09-16
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Streamline Navigated Instruments (K200095) | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2020-06-26 |